Neoplasms

All Conditions

Ear, Nose, and Throat Diseases

Nervous System Diseases

Symptoms and General Pathology

Rare Diseases

Neurilemmoma

Vertigo

Dizziness

Neuroma, Acoustic

Neuroma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Vestibulocochlear Nerve Diseases

Retrocochlear Diseases

Ear Diseases

Otorhinolaryngologic Diseases

Otorhinolaryngologic Neoplasms

Cranial Nerve Diseases

Schwannoma

Acoustic Neuroma

Neuroendocrine Tumor

Neuroepithelioma

Patients will undergo balance and hearing questionnaires before and after gammaknife radiosurgery.

This is a before/after analysis needing only one arm: the "before" data will serve as control to the "after" data

Patients will undergo questionnaires before the gammaknife radiosurgery, then one year and three years after the intervention.

gammaknife radiosurgery

Mathieu MARX, MD Phd

Mathieu MARX

Mathieu MARX, MD PhD

Vestibular schwannomas are benign lesions of the ponto-cerebellar angle that are potentially dangerous because of their growth in a cramped space and the compressive phenomena they can cause. Stereotactic Gammaknife radiosurgery is a treatment option that can be offered for evolutive schwannomas smaller than 2.5-3 cm in size. It allows tumor stabilisation in 85% of cases with less than 1% facial nerve damage risk.

There are controversial results regarding hearing preservation : percentages vary between 25 and 80% in the literature, depending on the criteria used and the post-treatment delay.

Few studies have investigated changes in vestibular function and the impact on balance of radiosurgery, and their results are variable.

These controversial results lead us to comprehensively assess the vestibular function and balance of these patients using a balance-specific quality of life questionnaire, in addition to objective overall vestibular assessments of vestibular function.

Vestibular schwannomas are benign lesions of the ponto-cerebellar angle that are potentially dangerous because of their growth in a cramped space and the compressive phenomena they can cause. Stereotactic Gammaknife radiosurgery is a treatment option that can be offered for evolutive schwannomas smaller than 2.5-3 cm in size. It allows tumor stabilisation in 85% of cases with less than 1% facial nerve damage risk.

There are controversial results regarding hearing preservation : percentages vary between 25 and 80% in the literature, depending on the criteria used and the post-treatment delay.

Few studies have investigated changes in vestibular function and the impact on balance of radiosurgery.Their results are heterogeneous, on one hand, indicating little worsening of symptoms, or even improvement in some studies. On the other hand, a 2017 study reported symptomatic worsening of caloric response deficits in 17.6% of cases. Vestibular function at high frequencies or for otolithic organs (utricle and saccule) has hardly ever been explored.

The largest cohort, reported in "gammaknife radiosurgery for vestibular schwannomas a quality of life evaluation" concerns 353 patients and shows that the overall quality of life of the patients treated is on average comparable to that of the general population but that the vertigo is more frequent in this population, with a more marked impact on the overall quality of life.

These controversial results lead us to comprehensively assess the vestibular function and balance of these patients using a balance-specific quality of life questionnaire, in addition to objective overall vestibular assessments of vestibular function.

Thus, the present study aims to assess the quality of balance of patients treated with Gammaknife radiosurgery for vestibular schwannoma at 1 year and 3 years after treatment.

Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma

Prospective Study : Long-term Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma EQUI-GAMMA

Questionnaire including 25 items with a "yes/no/maybe" answer possibility

Evaluate the evolution of hearing using data obtained during tonal audiometry (frequency by frequency between 250 Hz and 8 kHz, average hearing loss calculated on the frequencies 0.5, 1, 2, and 4 kHz)

University Hospital, Toulouse

Sensation Disorders

Neurologic Manifestations

Patient treated by radiosurgery gammaknife for a one side vestibular schwannoma

Patient treated by microsurgery resection for a one side vestibular schwannoma

This procedure use intense gamma ray, which are concentrated to the precise volume of the tumor that used to stop the progression of the tumor

Radiosurgery gammaknife

Classical surgical approach with oto-neurosurgery procedures

Microsurgery resection

Vestibular schwannoma is a benign tumor located on the vestibular nerve. Patient could present dizziness symptoms cause to the tumor, and at least after the treatment by gamaknife radiosurgery or microsurgery resection.

Only few studies keep the interest about dizziness symptoms and treatment modality in vestibular schwannoma.

In the study dizziness symptoms were compared before and after the treatment of vestibular schwannoma by radiosurgery gammaknife or microsurgery resection. 2 scales were used : dizziness handicap inventory (DHI) and dizziness functionnal scale (AAO).

Vestibular Evaluation After Vestibular Schwannoma Treatment

Vestibular Evaluation Before and After Treatment of Vestibular Schwannoma. Comparison of Gamma Knife Radiosurgery and Microsurgical Resection

The investigator use a standarised scale :

- Dizziness Handicap Inventory (DHI). This scale combines 25 questions with three answers for each proposition about dizzyness in daily life situation : everytime (quote 4), sometimes (quote 2), never (quote 0). The scores are summing to obtain a value on 100.

The scale is completed before and after the treatement. The investigator send the scale to the patient by mail way.

The investigator use a standarised scale :

- Dizziness Functionnal Scale (AAO), this is a scale quote from 1 (no symptoms of dizzyness) to 6 (major disability). The patient have to choise only one item that correspond to the condition.

The scale is completed before and after the treatement. The investigator send the scale to the patient by mail way.

House and Brackmann scale :

This scale is a standarised assessment of facial fonction from grade I : normal ; to grade VI : total paralysis.

Each scale is completed after the treatement.

This information is based on a question to the patient about the usefulness of hearing prothesis.

So there are 2 groups : useful hearing (normal hearing or used hearing prothesis) or useless hearing (unsused hearing prothesis)

The information is completed before and after the treatement.

Tumor control is based on MRI size description (in mm):

So there are 2 groups : controled or evolution of the tumor.

* for microsurgery resection group the investigator keeps interest about the remaining size
* for radiosurgery gammaknife group the investigator keeps interest about the stability or the reduction of the tumor

The result is completed after the treatement.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma	NCT04859335	Vestibular Schw...	gammaknife radi...	18 Years - 65 Years	University Hospital, Toulouse
Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma	NCT04859335	Vestibular Schw...	gammaknife radi...	18 Years - 65 Years	University Hospital, Toulouse
Vestibular Evaluation After Vestibular Schwannoma Treatment	NCT03670589	Dizziness	Radiosurgery ga... Microsurgery re...	18 Years -	University Hospital, Grenoble
Vestibular Evaluation After Vestibular Schwannoma Treatment	NCT03670589	Dizziness	Radiosurgery ga... Microsurgery re...	18 Years -	University Hospital, Grenoble
Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma	NCT04859335	Vestibular Schw...	gammaknife radi...	18 Years - 65 Years	University Hospital, Toulouse

Spots Global Cancer Trial Database for gammaknife radiosurgery